Spinal Stimulation + FES-Assisted Cough Training in SCI

Official title

Combined Transcutaneous Spinal Stimulation + FES-Assisted Cough Training in Acute SCI

Overview

The overall objective of this proposal is to determine if transcutaneous spinal cord stimulation (tSCS) delivered concurrently with functional electrical stimulation (FES)-assisted cough training (FES-Cough) is an effective intervention to improve cough strength and coordination in individuals with acute/subacute SCI.

Detailed description

The overall objective of this proposal is to determine if transcutaneous spinal cord stimulation (tSCS) delivered concurrently with functional electrical stimulation (FES)-assisted cough training (FES-Cough) can synergistically improve cough strength and coordination in individuals with acute/subacute SCI. Aim 1: Determine the efficacy of tSCS combined with FES-Cough in individuals with acute/subacute SCI to improve cough strength and respiratory function. Spirometric values and respiratory pressures will be assessed as well as breathlessness and hypophonia after 20 sessions of active tSCS combined with FES-Cough vs. sham tSCS combined with FES-Cough administered over 4-6 weeks Aim 2: Analyze the effect of tSCS combined with FES-cough on cough coordination and sequencing through a detailed analysis of cough partial expiratory flow-volume (CPEFV) curves and respiratory muscle EMG before and after each of the interventions, including comparative analysis of EMG cough activity between individuals with neurologic injury and healthy control participants.

Th hypothesis is that participants receiving tSCS + FES-Cough will demonstrate significantly greater improvements in unstimulated peak cough flow, normalized cough phase timing, and improved flow-volume characteristics compared to the sham + FES-Cough group.

Interventions

• Other tSCS combined with FES-Cough
  A clinician will don the electrodes on the participant for 20, 30 minute sessions 2 to 4 times per week for 4 to 6 weeks. tSCS will utilize multi-site stimulation at C3-C4 and T9-10, with simulation intensity being set for each electrode which produces a visible muscle twitch. FES will be set up by placing electode pads in the posterolateral positon on the trunk. Baseline stimulation parameters are 50Hz Frequency, 250-400μs pulse duration, altering monophasic waveform, amplitude dependent on p
• Other Sham tSCS + FES assisted cough
  A clinician will don the electrodes on the participant for 20, 30 minute sessions 2 to 4 times per week for 4 to 6 weeks. tSCS will utilize multi-site stimulation at C3-C4 and T9-10, with simulation intensity being set for each electrode which produces a visible muscle twitch. The sham group will have intensity will be ramped up to sensation for 1 minute then ramped down and turned off FES will be set up by placing electode pads in the posterolateral positon on the trunk. Baseline stimulation pa

Primary outcome measures

• Peak Cough Flow [Time frame: From time of enrollment, through intervention, up to follow up assessment approximately 10 weeks]
• Cough Partial Expiratory Flow Volume [Time frame: From time of enrollment, through intervention, up to follow up assessment approximately 10 weeks]

Secondary outcome measures (4)

• Maximum inspiratory pressure [Time frame: From time of enrollment, through intervention, up to follow up assessment approximately 10 weeks]
• Changes in electromyography (EMG) of respiratory muscles [Time frame: From time of enrollment, through intervention, up to follow up assessment approximately 10 weeks]
• Maximum expiratory pressure [Time frame: From time of enrollment, through intervention, up to follow up assessment approximately 10 weeks]
• Forced expiratory volume [Time frame: From time of enrollment, through intervention, up to follow up assessment approximately 10 weeks]

Eligibility criteria

Inclusion criteria

• Currently admitted for inpatient rehabilitation at Shirley Ryan AbilityLab
• History of traumatic spinal cord injury with Neurologic Level of Injury (NLI) C1-T1, and AIS A-C on admission exam
• Between 14-60 days from date of injury at time of enrollment
• Baseline PCF below 270 L/min
• Anatomical airway or tolerating occlusion of tracheostomy with either a one-way speaking valve or a cap for at least 60 minutes
• Medically cleared by the participants primary inpatient physiatry attending physician

Exclusion criteria

• Individuals with pre-morbid chronic pulmonary conditions, day-time ventilator dependence, uncontrolled autonomic dysreflexia, moderate to severe traumatic brain injury, developmental delay, diagnosis of active cancer, or secondary progressive neurologic disorder
• Individuals with contraindications to the interventions of interest:

• TSCS and Abdominal FES: pacemaker, compromised skin integrity under site of stimulation, implanted defibrillators, deep brain stimulator(s), uncontrolled epilepsy or seizures, pregnancy, recent myocardial infarct, diaphragmatic pacer
• TSCS: Severe osteoporosis
• Abdominal FES: unhealed rib fracture, sternal precautions, recent pneumothorax, spine bracing impacting ability to place stimulation pads.
• Individuals with medical instability impacting the safety and feasibility of participation including the inability to tolerate sitting upright >45 degrees for 15 minutes, acute unresolved medical complications as determined by study physician to be exclusionary, transferred to higher level of medical care for ≥5 consecutive days or >14 days total during trial period, and those with halo spine bracing
• Individuals who are currently enrolled in another interventional research study are excluded from participating to eliminate potential influence of additional experimental interventions on study outcomes and to maintain standardization of study protocol

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Shirley Ryan AbilityLab — Chicago

Identifiers

NCT: NCT07683780 · STU00225588 · 1529723

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗